MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-19 for TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF 412390406 manufactured by Icu Medical, Inc..
[139210526]
The device is expected to be returned for evaluation. It is yet to be received.
Patient Sequence No: 1, Text Type: N, H10
[139210527]
It was reported that during cardiac catheterization the balloon of the td torque-line catheter, 7f, 4 lumen, 110 cm, heparin coated, lf ruptured during insertion. There was patient involvement, but no adverse event, no delay in critical therapy, nor medical/surgical intervention required. The device was changed with no further problems encountered. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713468-2019-00011 |
| MDR Report Key | 8432833 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-04-05 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMILY ARNOULD |
| Manufacturer Street | 600 N. FIELD DR. |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2247062300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF |
| Generic Name | CATHETER, OXIMETER, FIBER-OPTIC |
| Product Code | DQE |
| Date Received | 2019-03-19 |
| Catalog Number | 412390406 |
| Lot Number | 92-324-HE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | 4455 S. ATHERTON DRIVE SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |